Avadel Pharmaceuticals drops Noctiva nasal spray

Avadel Specialty Pharmaceuticals, which marketed Noctiva desmopressin nasal spray in the US, has filed for Chapter 11 bankruptcy, parent company Avadel Pharmaceuticals announced. Less than a year after launching Noctiva in the US, Avadel said that it will no longer market the product.

Noctiva was approved by the FDA in March 2017 for the treatment of nocturnal polyuria (overproduction of urine at night) in adults, with a label including a boxed warning regarding the risk of hyponatremia.

In September 2017, Avadel paid Serenity Pharmaceuticals $50 million up front for US and Canadian rights to Noctiva, with $20 million due on launch. Avadel now says that dropping Noctiva is expected to save the company  $55 to $60 million in 2019.

According to Avadel, “Noctiva’s performance since launch has been highly disappointing despite a substantial investment of resources.   It no longer warrants such a level of support, and Avadel will be better positioned for the future by exiting the business entirely.”

The newly announced restructuring plan, which will refocus the company’s resources on its FT218 sodium oxybate development program, follows recent management changes. At the beginning of 2019, the company announced that CEO Michael Anderson had resigned; Gregory J. Divis was named interim CEO and Geoffrey Glass was named Chairman of the Board.

Glass stated, “following recently-announced management and board changes, we undertook a comprehensive review of our existing businesses and corporate strategy. The restructuring plan announced today marks an important step toward restoring Avadel’s financial health and creating a pathway to enhance shareholder value. This plan simplifies Avadel’s business, preserves capital, and creates needed focus and clarity. While the restructuring unfortunately affects a majority of our employees, this action is required to enable the company to maximize the value of FT218 for the treatment of narcolepsy.”

Read the Avadel Pharmaceuticals press release.

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